#United States #Tampa, Florida #Concept Medical #PAD #MAGICAL-BTK

Concept Medical Launches MAGICAL-BTK Study for PAD Treatment

On January 17, 2025, Concept Medical Inc., a global leader in innovative drug delivery technologies, announced a significant advancement in peripheral artery disease (PAD) treatment in the United States with the successful enrollment of the first patient in the MAGICAL-BTK IDE Study. This trial is designed to evaluate the effectiveness of the Sirolimus-coated balloon, known as the MagicTouch PTA, against traditional balloon angioplasty methods for treating arterial diseases below the knee.

The pioneering insertion of the first patient was undertaken by Dr. Prakash Krishnan and his team at the Icahn School of Medicine at Mount Sinai, representing a crucial milestone in enhancing treatment options for patients suffering from PAD. With this trial, Concept Medical embarks on its clinical PAD program, which focuses on improving patient outcomes through state-of-the-art medical technologies.

The enrollment is part of a larger IDE study following the approval from the U.S. Food and Drug Administration (FDA). Concept Medical is simultaneously engaged in another clinical trial focusing on coronary artery disease, positioning itself uniquely to potentially improve healthcare standards across multiple vascular fields.

Dr. Krishnan remarked, “Enrolling the first patient in the MAGICAL-BTK study is a crucial step toward improving standard care practices for lower extremity conditions associated with peripheral arterial occlusive disease. The Sirolimus-coated balloon technology has the potential to significantly enhance limb salvage and overall patient quality of life.”

The MAGICAL-BTK study will rigorously compare the safety and efficacy of the MagicTouch PTA Sirolimus Coated Balloon with the conventional percutaneous transluminal angioplasty (PTA). The primary endpoint will assess primary patency after 12 months, ensuring the study’s findings translate into meaningful clinical outcomes.

This global, multicenter trial is directed by Prof. Sahil Parikh and a distinguished group of study leaders, including Dr. Eric Secemsky, Prof. Brian DeRubertis, Prof. Edward Choke, and Prof. Osamu Iida, who collectively emphasize the importance of this research in offering hope to millions at risk of limb loss due to inadequate blood flow.

Prof. Parikh notes, “The commencement of the MAGICAL-BTK study heralds a new era in the treatment of patients suffering from chronic limb-threatening ischemia, granting renewed hope to those vulnerable to limb loss.”

With the Sirolimus-coated balloon technology already revolutionizing treatments for coronary and peripheral artery diseases in Asia and Europe, the MAGICAL-BTK study now extends these groundbreaking benefits to American patients. Additionally, the inclusion of participants from Asia in this study will generate a comprehensive understanding of the therapy's advantages across different populations.

Dr. Manish Doshi, founder and Managing Director of Concept Medical, stated, “Our unwavering commitment to innovation and patient care drives us to push the boundaries of what is possible in vascular interventions. The launch of the MAGICAL-BTK confirms our resolve to provide doctors and patients worldwide with next-generation evidence-based solutions.”

As Concept Medical prepares to implement the MAGICAL-BTK study and the MAGICAL-SFA-IDE study for superficial femoral artery treatment, their unique technology platform is poised to redefine endovascular care. Their pioneering products, such as the MagicTouch family of Sirolimus-coated balloons, have already made a significant impact, having been utilized in over one million patients globally, thus establishing a new standard in vascular therapy.

For further information about Concept Medical and its groundbreaking work in PAD treatment, visit Concept Medical's Website.